Questran Light

In the U.S.

• Prevalite
• Questran
• Questran Light

In Canada

• Novo-Cholamine
• Novo-Cholamine Light

Available Dosage Forms:

• Powder for Suspension
• Tablet

Therapeutic Class: Antihyperlipidemic

Pharmacologic Class: Bile Acid Sequestrant

This section provides information on the proper use of a number of products that contain cholestyramine. It may not be specific to Questran Light. Please read with care.

Take this medicine exactly as directed by your doctor. Try not to miss any doses and do not take more medicine than your doctor ordered.

This medicine should never be taken in its dry form, since it could cause you to choke. Instead, always mix as follows:

• Place the medicine in 2 ounces of any beverage and mix thoroughly. Then add an additional 2 to 4 ounces of beverage and again mix thoroughly (it will not dissolve) before drinking. After drinking all the liquid containing the medicine, rinse the glass with a little more liquid and drink that also, to make sure you get all the medicine.
• You may also mix this medicine with milk in hot or regular breakfast cereals, or in thin soups such as tomato or chicken noodle soup. Or you may add it to some pulpy fruits such as crushed pineapple, pears, peaches, or fruit cocktail.

For patients taking this medicine for high cholesterol :

• Importance of diet—Before prescribing medicine for your condition, your doctor will probably try to control your condition by prescribing a personal diet for you. Such a diet may be low in fats, sugars, and/or cholesterol. Many people are able to control their condition by carefully following their doctor's orders for proper diet and exercise. Medicine is prescribed only when additional help is needed. Follow carefully the special diet your doctor gave you, since the medicine is effective only when a schedule of diet and exercise is properly followed.
• Also, this medicine is less effective if you are greatly overweight. It may be very important for you to go on a reducing diet. However, check with your doctor before going on any diet.
• Remember that this medicine will not cure your cholesterol problem but it will help control it. Therefore, you must continue to take it as directed if you expect to lower your cholesterol level.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (powder for oral suspension):
  • For high cholesterol or pruritus (itching) related to biliary obstruction:
    • Adults—At first, 4 grams one or two times a day before meals. Then, your doctor may increase your dose to 8 to 24 grams a day. This is divided into two to six doses.
    • Children—At first, 4 grams a day. This is divided into two doses and taken before meals. Then, your doctor may increase your dose to 8 to 24 grams a day. This is divided into two or more doses.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

It is very important that your doctor check your progress at regular visits. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to take it.

Do not take any other medicine unless prescribed by your doctor since cholestyramine may change the effect of other medicines.

Do not stop taking this medicine without first checking with your doctor. When you stop taking this medicine, your blood cholesterol levels may increase again. Your doctor may want you to follow a special diet to help prevent this from happening.

• If you have an allergy to cholestyramine or any other part of Questran Light (cholestyramine resin).
• If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
• If you have a biliary tract block.

This is not a list of all drugs or health problems that interact with this medicine.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take Questran Light with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Signs of bleeding like throwing up blood or throw up that looks like coffee grounds; coughing up blood; blood in the urine; black, red, or tarry stools; bleeding from the gums; vaginal bleeding that is not normal; bruises without a reason or that get bigger; or any bleeding that is very bad or that you cannot stop.
• Very bad belly pain.
• Very hard stools (constipation).
• Very loose stools (diarrhea).

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Belly pain.
• Upset stomach or throwing up.
• Gas.
• Burping.
• Bloating.
• Loose stools (diarrhea).
• Not hungry.
• Hard stools (constipation). Drinking more liquids, working out, or adding fiber to the diet may help. Talk with the doctor about a stool softener or laxative.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else's drugs.
• Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
• Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
• Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about this medicine, please talk with your doctor, nurse, pharmacist, or other health care provider.
• If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

This information should not be used to decide whether or not to take Questran Light or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Questran Light (cholestyramine resin). This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using this medicine.

Review Date: October 4, 2017

Applies to cholestyramine: oral powder for suspension, oral tablet

In some animal studies, cholestyramine (the active ingredient contained in Questran Light) was found to cause tumors. It is not known whether cholestyramine causes tumors in humans.

Along with its needed effects, cholestyramine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking cholestyramine:

• Black, tarry stools
• stomach pain (severe) with nausea and vomiting

Check with your doctor as soon as possible if any of the following side effects occur while taking cholestyramine:

• Constipation

• Loss of weight (sudden)

Some side effects of cholestyramine may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Heartburn or indigestion
• nausea or vomiting
• stomach pain

• Belching
• bloating
• diarrhea
• dizziness
• headache

Applies to cholestyramine: compounding powder, oral powder for reconstitution

General

The most frequently reported side effect is constipation.[Ref]

Gastrointestinal

Intestinal obstruction occurred rarely and 2 deaths in pediatric patients were reported.[Ref]

Very common (10% or more): Constipation
Uncommon (0.1% to 1%): Tongue irritation, irritation of perianal area, abdominal discomfort/pain/distention, flatulence, nausea, vomiting, diarrhea, heartburn, dyspepsia, steatorrhea
Rare (less than 0.1%): Intestinal obstruction
Frequency not reported: Rectal bleeding, black stools, hemorrhoidal bleeding, bleeding from known duodenal ulcer, dysphagia, hiccoughs, ulcer attack, sour taste, pancreatitis, rectal pain, diverticulitis, eructation, dental bleeding, dental caries, calcification of gallbladder, tooth discoloration, erosion of tooth enamel[Ref]

Cardiovascular

Frequency not reported: Claudication, angina, arteritis, thrombophlebitis, myocardial infarction, myocardial ischemia, postprandial angina increased[Ref]

Musculoskeletal

Common (1% to 10%): Osteoporosis
Frequency not reported: Backache, arthritis, muscle/joint pain[Ref]

Hematologic

Uncommon (0.1% to 1%): Bleeding
Frequency not reported: Prothrombin time increased, prothrombin time decreased, anemia, hypoprothrombinemia[Ref]

Metabolic

Uncommon (0.1% to 1%): Anorexia, hyperchloremic acidosis, Vitamin A deficiency, Vitamin K deficiency[Ref]

Dermatologic

Uncommon (0.1% to 1%): Rash, skin irritation
Frequency not reported: Ecchymosis, xanthoma of hands/fingers, urticaria[Ref]

Hepatic

Frequency not reported: Liver function test abnormal[Ref]

Nervous system

Frequency not reported: Headache, paresthesia, syncope, dizziness, drowsiness, femoral nerve pain[Ref]

Other

Frequency not reported: Vertigo, weight loss, weight gain, glands swollen, edema, chest pain, tinnitus[Ref]

Ocular

Frequency not reported: Arcus juvenilis, uveitis, night blindness[Ref]

Genitourinary

Frequency not reported: Hematuria, dysuria, burnt odor to urine, diuresis[Ref]

Respiratory

Frequency not reported: Asthma, wheezing, shortness of breath[Ref]

Psychiatric

Frequency not reported: Libido increased[Ref]

Some side effects of Questran Light may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.